Get documents about "2-day In-person Seminar on Regulatory Compliance for Dietary Supplements in the US, EU and Canada at Boston
Description
A growing public demand for supplements has resulted in a flurry of companies creating and marketing dietary supplements in the United States, EU and Canada. With the regulatory authorities beginning to take a stronger stance on enforcement of regulatory policies, procedures and GMP compliance, it is important for companies to verify that their products comply with the latest regulations and provisions if they plan to market Supplements in these countries.
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- 8/1/2012
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2-day In-person Seminar on
Regulatory Compliance for Dietary Supplements in the US, EU and
Canada
Course "Regulatory Compliance for Dietary Supplements in the
US, EU and Canada " has been pre-approved by RAPS as
Register Now
eligible for up to 12 credits towards a participant's RAC
recertification upon full completion.
Date & Time: Instructor Profile:
September 13th and 14th 2012 8 AM to 5 PM EDT
James E. Russell
Duration: 2 Days Instructor: James E. Russell Director of Regulatory
Affairs, RJR Consulting Inc
Price : $1495.00 (for one
Location: Boston
participant)
Mr. Russell is the Director of
Register for 4 Participants to Get 1 Free Pass Regulatory Affairs and Business
Development for RJR Consulting Inc,
a leading global regulatory
consulting firm servicing the Life
Overview:
Science and Consumer Products
A growing public demand for supplements has resulted in a flurry of industries. Mr. Russell has 13 years
companies creating and marketing dietary supplements in the United of experience in the Life Science
States, EU and Canada. With the regulatory authorities beginning to field, encompassing foods, dietary
take a stronger stance on enforcement of regulatory policies, supplements, medical devices and
pharmaceuticals. James joined RJR
procedures and GMP compliance, it is important for companies to
Consulting in 2009 to assist
verify that their products comply with the latest regulations and
companies with their global
provisions if they plan to market Supplements in these countries. regulatory, manufacturing and
distribution needs.
This 2-day interactive live seminar will review the regulations that
impact Dietary Supplements in the US, EU and Canada and discuss Prior to RJR, Mr. Russell worked for
how to verify that products are compliant with these regulations. a large life science distribution
Differences with food and drug regulation in these countries will be company with organizational
responsibilities including regulatory,
noted as well. We will also cover what qualifies as a dietary
supply chain, business strategy and
supplement or dietary ingredient, how to ensure GMP compliance as
product data quality. Mr. Russell
well as detailed requirements for labeling and acceptable marketing currently teaches on a variety of
claims. An update on current events within the Supplement industry regulatory topics and is a
and the potential impacts to Manufacturers and Distributors in the participating member of the
US, EU and Canada will also be presented and discussed. Regulatory Affairs Professionals
Society (RAPS). ...more
Course Outline:
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Course Outline: Day 1:
Your Necessity is our Priority
Dietary Supplement Regulation in the U.S.
Lecture 1: Dietary Supplement Overview
l What is a dietary supplement?
l Supplements vs.
¡ Pharmaceuticals
¡ OTC Drugs
¡ Conventional Foods
¡ Medical foods
¡ Natural products
¡ Herbal medicinal products
Lecture 2: Organizations and Regulatory Structure
l FDA Structure regarding Dietary Supplements
l Industry Groups
Lecture 3: History of Dietary Supplement Regulation
l Early History
l DSHEA
l Code of Federal Regulations
Lecture 4: Manufacturing Considerations
l Company & Facility Registration
l GMP Requirements
l GMP inspections
Lecture 5: Dietary Ingredients
l What qualifies as a dietary ingredient?
l Old dietary ingredients vs. New dietary ingredients
l New Dietary Ingredient Notification (NDIN)
l Updated New Dietary Ingredient Guidance from FDA
Lecture 6: Labeling Considerations
l Display Panels & Layout
l Supplement Facts Panel
l Labeling Claims
¡ Health claims
¡ Disease Claims
¡ Structure/Function claims
¡ Disclaimers/Substantiation
l Notification of labeling claims to FDA
l Dietary Supplement Labeling Act
Lecture 7: Advertising Considerations
l FDA vs. FTC jurisdiction
l Enforcement
l Expressed vs. Implied Claims
¡ Exercises & examples
l Disclosures
l Claim Substantiation
l Testimonials
Course Outline: Day 2:
Food Supplement regulation in the EU
Lecture 8: Overview
l What is a food supplement?
l Borderline products
l Medicinal Foods
Lecture 9: Organizations and Regulatory Structure
l EU Regulatory Structure
l Industry Groups
Lecture 10: Supplement Regulation
l Early History
l Food Supplement Directive
Lecture 11: Manufacturing Considerations
l Company & Facility Registration
l GMP Requirements
Lecture 12: Dietary Ingredients
l What qualifies as a dietary ingredient?
l Ingredient safety
l RDA vs RDI
l DRV vs % Daily Value
Lecture 13: Labeling Considerations
l Display Panels & Layout
l Labeling Claims
¡ Health claims
¡ Disease Claims
¡ Reduction of Disease Risk Claims
¡ Nutrition Claims
l Notification requirements
Lecture 14: Advertising Considerations
l Enforcement
l Claim Substantiation
Natural Health Product regulation in Canada
Lecture 15: Overview
l What is a Natural Health Product?
Lecture 16: Organizations and Regulatory Structure
l Canadian Regulatory Structure
¡ Health Canada
¡ Canadian Health Products Directorate
Lecture 17: Supplement Regulation
l National Health Products Regulation
l Differences between Canada and US
l Supplements monographs
l Requirements for pre-market approval
Lecture 18: Manufacturing Requirements for Natural Health
Products in Canada
Lecture 19: Dietary Ingredients
Lecture 20: Labeling Considerations
Lecture 21: Advertising Considerations
Lecture 22: Enforcement and Post-Marketing Surveillance
Click here to register for this seminar
Who Will Benefit:
l Executives/Managers within Dietary Supplement or Natural
Product companies
l Regulatory Compliance Professionals in the Supplements or
Natural Products area
l Quality Assurance or Quality Control Professionals
l Dietary Supplement or Natural Product Manufacturers &
Distributors
l Sales/Marketing Personnel in the Supplement or Natural
Product Industries
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
Best regards,
Event-coordinator
GlobalCompliancePanel
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